Ref. Ares(2015)109988 - 12/01/2015
Ref. Ares(2016)6036878 - 20/10/2016
TTIP Meeting with European Coalition on Homeopathic and Anthroposophic Medicinal Products
explained the state of play of TTIP negotiations and gave some explanation of the method and
structure followed for TTIP negotiations. Negotiations take place around several pillars. The regulatory
pillar comprises the TBT text; regulatory coherence and the different sectors. Pharmaceuticals have been
tackled since the beginning of the negotiations (in Pharma there is an emphasis on GMP but other areas are
also being looked at). The list of sectors that have been discussed so far is the result of a public call for
interest of stakeholders launched in 2012. The information collected from this activity is available to the
public. In the US, a similar mechanism was used. In this context there were joint positions received from
associations from the EU and the US. On basis of these contributions and regulators input some sectors
were selected such as pharmaceuticals, medical devices, chemicals and so on. Currently, around 9 sectors
are being discussed. The sectors are handled together by DG Trade and other DGs that have the regulatory
expertise. This configuration is also followed by the US, where USTR and the experts (US Food and Drug
Administration, when it comes to pharmaceuticals) are present. Furthermore, COM has put a strong
communication strategy into place regarding TTIP: stakeholders meetings and publication of position
papers, among others.
explained that it represents around fifty companies which are located in around twenty MS. They
are mainly SMEs which produce homeopathic or antroposophic medicinal products in the EU. ECHAMP´s
work is highly specialized in as much as they deal with homeopathic therapies, for which there is a need for
a big product range of raw materials. ECHAMP is globally satisfied with the current EU framework and
showed concerns about a potential changes negotiated in the context of TTIP. ECHAMP highlighted that
there is an important number of Europeans that use these products and, therefore, ECHAMP wants to
ensure a proper regulatory framework and to ensure continued availability of these products in the EU
market. According to ECHAMP the pharmaceutical industry receives a lot of attention in FTAs; however,
herbal and homeopathic products should not be forgotten.
ECHAMP asked whether TTIP may have implications on marketing authorizations that are to a large extent
provided at national level. COM explained that national authorisations and mutual recognition of marketing
authorizations within the EU is not being discussed in the negotiations. This being said, some aspects/parts
of the marketing authorization process are being discussed, e.g. GMP, scientific advice or scientific
assessment. These discussions might further harmonise the data that are required in the EU and the US to
obtain a marketing authorization but the authorization procedures and the final decision on granting or not
a marketing authorization will remain unchanged.
ECHAMP indicated that they were in favor of mutual recognition of Good Manufacturing Practices
inspections. ECHAMP explained that their companies are normally audited by MS authorities and if the
intention is to export to the US, FDA carries out also a GMP inspection. of the underlying principles of
inspections by FDA and the EU are similar although inspections as such are not completely the same (e.g.
documentation to be provided might differ). Given the current scenario, it would be good to have further
harmonization. For example, there is an agreement of this kind between Brazil and the US. COM asked
ECHAMP to provide more information on this agreement.
ECHAMP noted that the status of their products in the EU and the US it is very important, in particular,
because some homeopathic products are seen as food supplements in the US where in the EU are
considered as medicinal products. This is crucial with regard to licensing of products. COM clarified that the
classification of products is not being discussed in TTIP. In this respect ECHAMP inquired whether a US food
supplement could be sold as an homeopathic product in the EU after TTIP. COM noted that FTAs do not
amount at allowing that any product that is authorized in the US can be directly sold in the EU. EU
procedures or legislation will not be amended as a result of TTIP. Furthermore, the products will have to
continue complying with the rules/legislation of the country of destination. There is therefore not such risk.
ECHAMP noted that one of the challenges is that these products are not normally regulated via centralized
procedure but at national level. Thus, nowadays, this industry is subject to EU Regulations/Directives,
national rules and ICH but there are also national guidelines. The implementation of the latter differs upon
MS, i.e. there is not a harmonized approach in the EU on the authorization of these products. ECHAMP
inquired therefore how to harmonize something that is not even harmonized in the EU. ECHAMP wants to
make sure that after TTIP or CETA their products can be kept in the market. COM noted that harmonization
on requirements is not being discussed in TTIP.
ECHAMP inquired about ISDS and Dispute Settlement provisions. In particular ECHAMP is concerned about
the possibility of American companies bringing actions against the EU or its MS on grounds of the lack of
harmonization that governs the EU market in the area of homeopathic and and antroposophic products.
ECHAMP illustrated the question by giving an example in which a US product enters the EU market through
a MS but finds a barrier when trying to access another MS market (where the same product is not
COM noted that each party keeps the right to protect its interests on grounds of health and safety as it
happens in the scope of the TBT agreement. COM would look into Dispute Settlement provisions and
On food supplements COM noted that some associations have raised their voice on health claims (e.g.
AHPA). COM has also got requests on the maximum level of vitamins and minerals and on botanicals in
food supplements. However, COM did not consider it could move forward on these areas, EU legislation is
ECHAMP asked whether reimbursement will be affected by TTIP or CETA. COM noted that the EU system
legislation will not be changed neither MS competencies. Pricing and reimbursement decisions, as such, are
national competences but there is an EU Directive that ensures transparency of the decision process. In the
EU-Korea FTA there are provisions on transparency regarding pricing and reimbursement. When the EU
negotiates with certain countries that lack this type of transparency provisions, the EU tries to push these
provisions into the agreement. Nonetheless, for this to be possible the other party needs to have a similar
system to the EU one. Between the EU and the US, there are too many differences. In addition there is EU
legislation on transparency. Therefore, there is no need to put provisions on transparency of pricing and
reimbursement decisions in TTIP.
ECHAMP was interested in knowing whether national regulatory agencies are normally involved in
negotiations or consultations. COM noted that for technical issues COM works with national agencies. For
example, there is a team of inspectors from MS for GMP inspections and COM works very close with EMA
on all scientific matters.
ECHAMP asked about how "regulatory cooperation" would work in relation to future legislation. Namely,
ECHAMP wanted to know whether there will be a Committee to deal with consultation on upcoming
legislation and whether it would constitute a mere consultation or it may influence the legislator's line to
take. COM noted that the Regulatory Council was an idea that was launched but it has not been fully
developed yet. The Regulatory Council will be a consultative body. At the international level there are
already mechanisms of notification for new regulations (SPS, TBT…) but bilateral consultations at early
stage could be useful. The usefulness of an FTA in this respect is that, where one of the parties is
developing new legislation, consultation with the other party will be carried out. Consultation does not
force however parties to change their legislation.
Finally, information on how to participate in Stakeholders meetings was given and potential work with the
sister ECHAMP organization in the US was mentioned as a possibility.
ECHAMP committed to further elaborate on the issues of their concern and to provide the COM with a
comprehensive document in this regard.